Abstract | OBJECTIVE: DESIGN: A doubleblind randomized controlled trial. SETTINGS: Tertiary care hospital. METHODS: Healthy term neonates were randomized to receive 1 mg of either phytomenadione (Group I, n = 85) or menadione (Group II, n = 85) intramuscularly within 2 hours of birth. PIVKA-II, a sensitive and specific marker of vitamin K deficiency was measured by ELISA method (Diagnostica Stago, France). Plasma level > 2 ng/mL was labeled as detectable PIVKA-II. RESULTS:
Birth weight (2914 +/- 318 vs 2958 +/- 312 g), gestation (38.4 +/- 1.2 vs 38.4 +/- 1.0 wk) and other baseline variables were comparable between the two groups. 48.2% (41/85) neonates in Group I and 44.7%(38/85) neonates in Group II had detectable PIVKAII levels ([Relative Risk (95% confidence interval): 1.1 (0.8-1.5); P = 0.76]). Median PIVKA-II levels in Group I and Group II were 1.99 ng/mL and 1.97 ng/mL respectively (P = 0.26). At 72 +/- 12 h of age, mean packed cell volume and mean serum bilirubin levels were comparable in the two groups. CONCLUSION: Comparable PIVKAII detection rate and PIVKAII levels in neonates receiving phytomenadione or menadione indicate their similar efficacy in prevention of vitamin K deficiency. However, high PIVKAII detection rate observed with both preparations indicates recent vitamin K deficiency and may be due to either inadequate dose of vitamin K or persistence of PIVKAII of fetal origin.
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Authors | D Chawla, A K Deorari, R Saxena, V K Paul, R Agarwal, A Biswas, A Meena |
Journal | Indian pediatrics
(Indian Pediatr)
Vol. 44
Issue 11
Pg. 817-22
(Nov 2007)
ISSN: 0974-7559 [Electronic] India |
PMID | 18057477
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- Protein Precursors
- Vitamins
- acarboxyprothrombin
- Vitamin K 3
- Vitamin K 1
- Prothrombin
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Topics |
- Biomarkers
(blood)
- Humans
- Infant, Newborn
- Protein Precursors
(blood)
- Prothrombin
- Vitamin K 1
(therapeutic use)
- Vitamin K 3
(therapeutic use)
- Vitamin K Deficiency
(diagnosis, prevention & control)
- Vitamins
(therapeutic use)
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